FDA-Device2013-04-03Class II
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM70SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Cardinal Health
Hazard
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Sold states
Worldwide Distribution - USA (Nationwide) and the countried of Australia, Canada and Japan.
Affected count
Cat. No. 4FA70SSA: 1,248; Cat. No. 4FM70SSA: 43,920
Manufactured in
1430 Waukegan Rd, Mc Gaw Park, IL, United States
Products
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM70SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0985-2013Don't want to check this manually?
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